Not currently registered with FDA under this name

Britesmile, Inc.

North Attleboro, MA, United States. Named as applicant on 2 dental 510(k) clearances between 2001 and 2004. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 22001–2004
Markets registered in: 22 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 2 markets

Where regulators' registries name Britesmile, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Britesmile, Inc.	2 clearances	2001–2004	Below
Taiwan	TFDA	Manufacturer	BRITESMILE, INC.	2	2006–2006	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Britesmile, Inc. as the applicant.

Decided	510(k)	Device	Device type
2 Apr 2004	K040797	BRITESMILE MASKING CREAM	EIE Rubber Dam
5 Sep 2001	K010935	BRITESMILE BARRIER MATERIAL	EIE Rubber Dam

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.